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Based on staff interviews, review of medical records, hospital policies and observations it was determined the hospital failed to meet the Condition of Participation (CoP) for Governing Body when they failed to ensure there was an effective Governing Body that was legally responsible for the conduct of the hospital.

Findings include:

1. The Governing Body failed to ensure that three (#3, #4 and #6) of six sampled medical staff (MS) members had current reappointments to practice in this hospital. Refer to A 0047

2. The Governing Body failed to develop, implement and maintain an effective, ongoing, hospital-wide, date-driven quality assessment and performance improvement program. Refer to A 0263

3. The Governing Body failed to ensure that an operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon for two of seven sampled surgery patient records (#18 and #35). Refer to A 0959

4. The Governing Body failed to ensure that a post anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia for two of 46 sampled patients (#35 and #36). Refer to A 1005



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5. The Governing body failed to ensure that medical staff was accountable for the quality of care provided to patients, appointments/re-appointments of medical stafff members, and involvement in the QAPI program. Refer to A0347.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview, record review and review of policies and procedures, the facility failed to meet the Condition of Participation (CoP) for Quality Assessment and Performance Improvement (QAPI) when they failed to meet and identify concerns throughout the hospital. The hospital failed to develop, implement, and maintain an effective, ongoing, hospital wide QAPI program that identified facility wide concerns with plans of action and measurable goals with time tables to ensure that the identified concerns would not continue in the future.
They failed to develop interventions, plans of action and performance improvement plans for:
1) Patient complaints and grievances,
2) pain management and medication administration,
3) maintenance and operation of essential kitchen equipment and
4) ensuring that the Quality Management Oversight Committee (QMOC) members were represented at each meeting to provide oversight for each QAPI team.
5) Additionally, the Hospital failed to address the findings from the 7/16/15 EMTALA investigation and failed to ensure that the Plan of Correction provided to correct the deficient practices was monitored and implemented.

Findings include:

1. An interview with the Supervisory Engineer/Acting QAPI Coordinator and the Performance Improvement (PI) Administrator on 10/27/15 at 11:30 AM, revealed that the facility had three different QAPI teams; one for Nursing Staff, one for Ancillary Staff and another for Medical Staff. The QAPI Coordinator stated that on a monthly basis, each of the three QAPI team members would hold a meeting to discuss each department's individual problems and potential concerns. Once the minutes from the team meeting had been documented, the information would be given to the "Quality Management Oversight Committee" (QMOC). The QMOC members were responsible for developing plans of action with measurable goals and time tables to ensure that the identified concerns from each QAPI team meeting would be prioritized, addressed and managed to ensure that the identified concerns would not continue in the future.

2. Review of the QMOC minutes revealed that the committee members did not analyze and track indicators relative to patient grievances and complaints; consequently they did not develop plans of actions with measurable goals and timetables to ensure that the patient complaints/grievances would not continue in the future. Refer to A0273.

3. Review of the QMOC minutes revealed that the committee did not analyze and track indicators relative to acute and chronic pain that was experienced by their patients; consequently the QMOC committee did not develop plans of actions with measurable goals and timetables to ensure that each patient's pain would be addressed and managed in the future. Refer to A0283.

4. Review of the QMOC minutes revealed that the committee failed to review the documented issues and concerns from each QAPI meeting to ensure that there was an ongoing Performance Improvement (PI) Plan for each department of the hospital. The QMOC did not: 1) Analyze and track indicators relative to patient grievances and complaints, 2) develop a plan of action relative pain management and medication administration, and 3) monitor the operation of the kitchen to ensure that the essential equipment could be maintained and operated in a safe and functional fashion. Refer to A0297

5. The Governing Body/Executive Committee failed to complete their responsibilities to oversee the QMOC to ensure that each member was represented at each monthly meeting; consequently the absent committee members could not develop a plan of action with measurable goals with timetables to ensure that the identified concerns could be prioritized, addressed and managed effectively. Refer to A0309

6. Review of the facility's policies and procedures revealed a document titled, "QAPI Plan" revised on 11/21/13 which provided the following information:

"Policy
The QAPI program develops, implements, and maintains an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The QAPI program reflects the complexity of the (name of the facility) Service Unit services. The QAPI program involves all Service Unit departments and services, including those services furnished under contract or arrangement. The QAPI program focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors ... "

" ...The QAPI Supervisor is responsible for ensuring quality indicators are identified, measured, analyzed, and tracked, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations. The QAPI Supervisor reviews all QAPI reports and provides summary information to Leadership and Governing Body. QAPI Supervisor recommends Performance Improvement Projects annually.

Performance Improvement (PI) Coordinator is responsible for collecting all department performance improvement activity reports. PI Coordinator analyzes all reports to ensure that there is measurable improvement or a corrective action plan that will show measurable improvement. The PI Coordinator reports monthly to the QAPI Supervisor at QAPI Department meetings... "

" ...Patient Advocate is responsible for processing, tracking and ensuring resolution to patient grievances. The Patient Advocate reports monthly to the QAPI Supervisor at QAPI Department meetings ... "




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7. On 10/29/15 in an interview with the IC (Infection Control) nurse (coordinator) revealed she was involved with monthly infection control meetings however she was not part of the overall hospital wide QAPI (Quality Assessment and Improvement) committee. She was not aware how departments were monitoring infection control practices. She expressed concerns with getting staff to be involved with a comprehensive hospital-wide infection control program. (Refer to A0749)


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8.The Hospital failed to implement the Plan of Correction for the EMTALA investigation (7/16/15).

Review of the Hospital's Plan of Correction (POC) revealed that "The ED Director will report a summary of performance for the department overall to QAPI during monthly Emergency Services Team meetings and quarterly in QAPI reports. The reports will be reviewed for effectiveness monthly during Emergency Services Team meetings and quarterly during QAPI meetings."

Review of the QAPI minutes evidenced that the last overall QAPI committee meeting occurred in April, 2015. The acting QAPI coordinator verified that Medical Staff meet but do not always have a quorum as providers do not attend the required meetings. She also confirmed that the data collected was not reviewed by the committee as the committee was not meeting.

Based on record review and staff interview, it was determined that the Medical Staff failed to evaluate the care provided by the Medical Staff and to do periodic appraisals, to credential staff as required, and to ensure qualifications for those appointments.

Findings included.

See the following for details:

A0047 Standard: Medical Staff Credentialing. The Medical Staff failed to examine credentials of candidates for Medical Staff membership and make recommendations to the Governing Body on the appointment of candidates in accordance with governing body bylaws.

A0273 Standard: Review of the QMOC meeting minutes for the months of January, February, March, and April 2015 revealed that the QMOC committee did not discuss the patient complaints or grievances that were documented in the "Patient Advocate Reports(s)." There was no evidence the medical staff was actively involved.

A0283 Standard: Review of the Quality Management Oversight Committee (QMOC) meeting minutes revealed that the committee members did not discuss the pain management and medication issues that were documented in the "Patient Advocate Reports".

A0297 Standard: Review of the QMOC meeting minutes revealed that the committee members did not discuss the poor attendance at the meetings and they did not develop a performance improvement program to ensure that the appropriate members would be available to attend the meeting in the future. Additionally, a follow up investigation to the 7/16/15 EMTALA investigation showed the Hospital failed to address the findings and ensure that the Plan of Correction provided to correct the deficient practices was monitored and implemented. The medical staff failed to ensure quality medical care was being provided to patients by the hospital.

A0347 Standard: Medical Staff Accountability. The Medical Staff failed to be accountable for the quality of care provided to patients.

Based on staff interviews, review of medical staff records and medical staff bylaws, the Governing Body failed to ensure that three (#3, #4 and #6) of six sampled medical staff (MS) members had current reappointments to practice in this hospital.

Findings include:

1. Review of the credentialing file of MS#3 on 10/27/15, revealed the initial provisional appointment notification letter dated 9/24/14 awarded MS#3 a medical staff appointment from 9/15/14 to 9/15/15. On 10/27/15 at 1:00 PM, the Medical Staff Coordinator (Employee #37) was asked to locate the documentation of the reappointment in the credentialing file but she was unable to do so. She stated "there is no documentation in this record."

2. Review of the credentialing file of MS#4 on 10/27/15, the initial provisional appointment notification letter dated 5/13/14 awarded MS#4 an appointment from 5/6/14 to 5/6/15. On 10/27/15 at 1:00 PM, Employee #37 was asked to locate the documentation of the reappointment in the credentialing file but she was unable to do so. She stated "there is no documentation in this record" regarding MS#4's reappointment.

3. Review of the credentialing file of MS#6 revealed the initial provisional appointment notification letter dated 10/20/14 awarded MS#6 a medical staff appointment from 10/15/14 to 10/15/15. An interview with Employee #37 on 10/27/15 at 2:30 PM confirmed there was no reappointment letter in the file of MS#6, nor was there evidence of peer review.

Review of the "Medical Staff Bylaws, Rules & Regulations for the USPHS (United States Public Health Service) Indian Health Service Pine Ridge Service Unit" require provisional staff serve "a probationary period (1 year)"and"Prior to the expiration of the provisional appointment period, the Clinical Director will determine whether to: 1. Convert the provisional appointee to regular, full-time status; 2. Extend Provisional status for a designated period of time; or, 3. Terminate membership and privileges."

During an interview conducted on 10/28/15 at 10:15 AM, the Area Medical Director stated he had not been notified by Employee #37 of the three medical staff members who were functioning without privileges. He stated the status of the three had not been discussed by the governing body. He stated "they can't work, they can't see patients."

Based on observations and staff interviews, the hospital failed to ensure each patient's privacy and safety requirements were met.

Findings include:

1. On 10/26/15 at 10:30 AM, during a tour of the pre-operative area, a bathroom used by patients did not have an emergency cord or button. At that time, the designated surgical lead, Employee#41 confirmed that there was no emergency communication device and there was no way for a patient to signal for help from that bathroom.

2. On 10/26/15 at 11:35 AM, during a tour of the operative area, a scalpel was found on top of a dusty equipment cart just outside of the sterile corridor. At that time, Employee#41 stated "that shouldn't be there" and removed it. At 2:30 PM on 10/26/15 a syringe cart located in the pre-operative suite near the patient entrance was found to be unlocked with scalpels, needles and intravenous start kits inside. The cart was readily accessible to patients, including prisoners, and visitors as they entered the area.



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3. Review of the Emergency Room (ER) record for patient #6's 10/16/15 visit to the Emergency Department (ED) at 2:36 PM revealed that the patient was brought in by the police for suicidal ideation. She assessed by the nurse, ED provider, and a behavioral health staff member who determined that the patient was "too vulnerable to be released via a safety plan" and needed transfer to an inpatient setting for further evaluation and assistance. Since no inpatient behavioral beds were available, the patient was to be admitted to the ACN with a sitter who was to be with her all the time. The patient was transferred to the ACN on 10/17/15 at 12:15 AM.

Review of the care plan developed by the ACN admitting nurse lacked evidence that the patient was to have a sitter at all times.

Review of a nursing note written on 10/19/15 at 12:45 PM "Patient friend/family notified charge nurse that the patient gaurdian/pt would be leaving the facility and IHS did not have legal document to keep pt. Charge nurse informed me, Behavior Health called and informed of the matter. Behavioral Health informed via telephone. At this time, pt was seen by another staff member leaving the facility, accompanied with caregiver, family member and ____(name) and followed by sitter, ____(name). Security called and notified.

Review of a Behavioral Health note written at 2:06 PM on 10/19/15 revealed that the patient was accepted at ____(name of hospital). Patient eloped and left the floor before the transfer could take place.

Review of patient's medical record evidenced a Tribal Court document placing a mental illness hold on the patient at 10:40 (AM) on 10/17/15.

On 10/28/15 at 10:24 AM, in an interview with the Area Clinical Director, Area Nurse Consultant, Acting Clinical Director, ED Medical Director, and the Director of Nursing (DON), the topic of the use of sitters to monitor patients was discussed. Per the discussion, sitters are to have background checks and have basic life support training. Their role is to provide 1:1 monitoring. Due to the elopement of the patient #6, a root cause analysis (RCA) was done. The DON verified that the role of the sitter would be clarified and the sitters would be educated to ensure that patients did not elope while under the watch of a sitter.


4. Review of the Emergency Room (ER) record for patient #32's two visits to the Emergency Department (ED) on 9/26/15 revealed that the patient was brought in by the police for a medical clearance to go to jail. The patient's chief complaint was chronic pain with shoulder pain.

The documentation on the first visit at noon evidenced that because of an issue in the community, the police released the patient from their custody at 1:15 PM. The patient was discharged to a parent at 2:20 PM.

The charting for the second visit revealed that the patient arrived in the ED at 8:18 PM and was intoxicated. The provider (B) arrived at the patient's bedside at 8:20 PM. The provider ordered laboratory tests. At 8:54 PM, the patient's blood was drawn. The patient's ethanol level was 252 mg/dL and he tested positive for THC. The patient's plan was "Discharge to jail. Return to ER when sober", timed at 10:45 PM. The provider noted that the patient eloped from the ER at 10:51 PM.

The nurse charted that at 10:30 PM the family member arrived to the ER. She noted that at 10:40 PM the patient was no longer in the bay and was visualized ambulating out of the facility with steady gait with family member.

There was no evidence to show that the plan, which was for the patient to go to jail, included the use of security to ensure that the patient remained in the ER until the police arrived. This would be a protective measure for the patient who was intoxicated. Additionally, because the patient wanted the intravenous access (PICC line) removed and he was intoxicated, he needed to wait until he could make an informed decision.


5. On 10/26/15 at 11:12 AM, during an observation of the Emergency Room (ER) in exam room #1, the cupboard above the sink was not locked. The cupboard contained boxes of needles, syringes, Saline flush in syringes. Under the sink which was not locked, there was a spray can of multiple purpose cleaner and two spray cans of Lysol disinfectant. The nurse (D) verified that the cupboard should be locked and there was to be nothing under the cupboard. The nurse had the one key available to lock the cupboard and confirmed that there were cupboards in each of the five exam rooms which contained the same supplies and were not kept locked.

The exam rooms have privacy curtains which were pulled across the opening to the rooms. Patients and family/visitors were observed to be left alone in these rooms, out of the view of the ER staff.

On 10/28/15 at 9:20 AM, during an observation of the ER, the exam rooms #1, #3, and #5 had unlocked cupboards which contained boxes of needles, syringes, and pre-filled saline flushes as well as IV start trays. Under the sink in exam room #3 there was a spray can of Lysol disinfectant spray.


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6. On 10/26/15 at 11:30 AM, an observation during the initial tour revealed an oxygen cylinder tank standing unsecured next to crash cart located at the nurse's station. Further observation on 10/27/15 at 3:30 PM, revealed the oxygen cylinder remained unsecured, standing on the floor, at the nurse's station.

On 10/27/15 at 3:30 PM, an interview with the Registered Nurse (RN) Team Leader, confirmed the oxygen cylinder was required to be secured at all times to prevent the cylinder from falling.

Review of the Hospital policy titled "Compressed Gas and Oxygen Use #3007", revised 10/15/15, revealed "PROCEDURE: GENERAL STANDARDS " which stated cylinders were to be secured on rack and oxygen cylinders were to be stored upright and secured.

Based on observation, staff interviews and review of the facilities policy and procedures the facility failed to follow policy and procedures that had been established in an attempt to protect patients, staff and visitors. The findings included:
1. During an interview with a nurse (CC) in the outpatient department on 10/29/15 at 10:30 AM, a patient was observed leaving an exam room. The patient was wearing a striped orange and white shirt and pants and was noted to be wearing metal ankle cuffs /shackles. The nurse reported that the patient was a prisoner and had been left unattended in an outpatient exam room. The patient was observed taking herself down two hallways and out into the main outpatient waiting area. Nurse (CC) reported the prisoner had been seen by a practitioner without security or guard in attendance. The nurse (CC) also reported that not all prisoner in shackles had security with them at all times when they are brought into the outpatient clinic. She was also unsure about a policy or if prisoners were always supposed to have security with them. The outpatient nurse supervisor (AA) joined the discussion and nurse (CC) asked nurse (AA) if prisoners were supposed to have security at all times and what the policy was. She reported prisoners have been left unattended in the past but was unsure of the policy.
The nurse supervisor (AA) then said she would follow up and went to the waiting area where two prisoners were observed. The prisoners, one male and one female, were both wearing metal ankle cuffs /shackles but were seated in different areas. One prisoner was seated with other patients in outpatient waiting room and the second prisoner was seated in a hallway by pharmacy with a police officer/guard. He confirmed he was with both prisoners. However the nurse confirmed he was unable to monitor two prisoners at the same time if one prisoner had to go to a different room or area of the hospital for an exam which just occurred.
a. At 10:45 AM the surveyor went to interview the DON (Director of Nursing) accompanied by nurse (AA). The DON reported that the police officer/guard is supposed to remain with any prisoner at all times and they are not to be left unaccompanied with staff. The DON reported they did have policies which addressed that issue. She then reported it was addressed in a restraint policy and a security policy which were later provided. The DON instructed nurse (AA) to notify security and reeducate staff on notifying security when it occurs so prompt follow up can be done.
b. Review of the policies included:
1) "Patient In Law enforcement/Corrections Custody" dated 10/2011 stated, "It is the policy of this hospital that patients under legal, or correctional restrictions are treated with a primary focus on the medical needs of the patient, this type of patient population imposes special circumstances in the provision of care and treatment, as such, the following procedure will be followed.
In the event of a situation, a patient under legal or correctional restrictions has presented to the facility, the following procedure applies:
Emergency and Outpatient Services: All inmates being seen in the Emergency Department or the Outpatient Clinics will have an individual law enforcement officer with the patient at all times..." It also included, "Conduct of Officers: Law Enforcement Officers are to remain in the patient's room, approval for hallway location will be obtained from hospital staff for conditions such as isolation, equipment congestion, unresolved problems regarding the management of the patient will be reported to administration for follow-up."
2) "Restraint Policy" dated 3/13/15 included, "B. Exemptions from requirements of the restraint or seclusion standards include: The use of handcuffs or other restrictive devices applied by law enforcement officials who are not employed or contracted by the hospital when the use of such devices is for custody, detention and public safety reasons and is not involved in the provision of health care. The application, monitoring, and removal of forensic devices are responsibility of the law enforcement officers. the hospital and its staff are responsible for providing safe and appropriate care to the patient..."

2. On 10/29/15 at 10:40 AM, a female in a white and orange jumpsuit and in handcuffs and shackles was escorted to a room in the preoperative area by a guard in uniform who then exited the area. There was no one guarding or monitoring the female.

The facility was not enforcing its current policies to ensure a safe patient environment by not having a police officer with patients/prisoners at all times.

Based on observation and staff interview, it was determined the hospital failed to ensure the confidentiality of patient records.

Findings include:

1. On 10/26/15 at 10:30 AM and 10/29/15 at 10:40 AM, during observations of the pre-operative and post anesthesia care area computer monitor screens were noted to be visible to patients and visitors. The screens contained patients' information.

2. An interview conducted on 10/26/15 at 3:20 PM, revealed that the Health Information Management (HIM) Administrator's (Employee #9) computer monitor had a privacy screen in place to prevent unauthorized observations of patient records and further stated all computer monitors in the facility should have privacy screens.


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3. On 10/26/15 at 11:20 AM, during an observation in the Emergency Department (ED) in the presence of the Acting CEO and nurse (D), the physician's charting room was observed. The door was observed to be left open, even when no provider was using the room. On the counter under the cabinets, there was a stack of medical records. The nurse verified that those were patient records which had deficiencies that staff needed to correct. These records were not secured from unauthorized access.

Based on medical record review, policy review, and staff interview, it was determined that the Hospital failed to assess the continued use of restraints for the one of one restrained patients (#31) from a sample of 46 patients.

Findings included:

Review of the Emergency Room (ER) record for patient #31's 10/20/15 visit to the Emergency Department (ED) revealed that the patient was "intoxicated" and "combative" and had a complaint of shortness of breath.

The nurse charted that the patient was given Haldol 10 mg IM and Lorazepam 2 mg at 11:40 PM. (Note: The physician order in the medical record was for 5 mg Haldol). Within 35 minutes of the patient receiving these medications, she was noted to be sleeping soundly, as evidenced in the following assessments for the physical restraints.

The patient's nursing notes at 11:35 PM evidenced that the patient was in 4 point restraints per order due to the patient continuing to "bite, scratch, kick and remains uncooperative. Hallucinating at times and talking uncoherently and crying. Orders received and placed per protocol."

At 12:15 AM, the patient was"sleeping soundly"..

At 12:30 AM, the patient was "sleeping, moving around, lifting head and talking incoherently, pulling at restraints".

At 12:45 AM, 1:00 AM, 1:15 AM, 1:30 AM, 1:45 AM, 2:00 AM, 2:15 AM, 2:30 AM, and 2:45 AM, the patient was noted to be sleeping. At 2:45 AM, the note indicated "attempting to wake patient without success." At 3:15 AM, the charting noted "continue to attempt to awaken patient, cooperative..." At 3:30 AM, "patient woke, .... 3 restraints removed...Patient awake et groggy, talks, and cooperative." At 3:45 AM, the note indicated "attempting to awaken patient with some success. OOB (out of bed) and ambulated down hall with two RN's assisting. Patient reports felling 'groggy'. Returned back to bed .." At 4:00 AM, patient was noted to be "sleeping".

The nurse charted that at 4:30 AM, the patient was discharged to jail.

Review of the patient's Restraint Flow Sheet, dated 10/20/15, started at 11:35 PM, evidenced every 15 minute documentation. The patient was assessed to be sleeping from 11:50 PM to 3:35 AM. At 3:20 AM, one restraint was removed. At 3:35 AM, the patient had only one restraint on. At 3:50 AM, the restraints were off the patient.

No physician order for the restraints was found in the medical record which was provided to the surveyor on 10/28/15 at 3:50 PM.

Review of the Hospital's Restraint Policy with a revision date of 3/10/15 revealed the following:

"D. Standard for Use:
4. Must be discontinued at the earliest possible time."

"H. Registered Nurse Responsibility:
7. Implementing a time ordered restraint does not require application of the restraint for the entire time period if the patient demonstrates a reduction in the behavior that led to being placed in restraints.

9. Criteria for early release from restraints
(1) The medical need for restraint is no longer present
(3) There is a reduction in the initial behavior that led to restraint..."

On 10/29/15 in an interview with the Director of Nursing, she verified that the nurse should assess the ongoing use of restraints when the patient is calm and sleeping, as was the case with this patient.

Based on interview, record review and review of the policies and procedures, the facility failed to ensure that their Quality Management Oversight Committee (QMOC) had an ongoing program that indicated measureable improvements and outcomes for identified concerns. The QMOC did not analyze and track indicators relative to patient grievances and complaints; consequently they did not develop plans of actions with measureable goals and timetables to ensure that the concerns would not continue in the future.

Findings include:

An interview with the Patient Representative on 10/27/15 at 11:30 AM revealed that she was a fairly new employee and she had just begun collecting data relative to the many complaints and grievances that she received from patients. The Patient Representative stated that she had been collecting data since January 2015 and she memorialized the information in a pamphlet titled, "Patient Advocate Report(s)" Once the monthly reports were complete, she delivered the pamphlet to the "Leadership" committee. She added that the Leadership committee was responsible for providing the "Patient Advocate Report(s)" to the Quality Management Oversight Committee (QMOC)." The Patient Representative stated that she had not been invited to any of the QMOC meetings.

Review of the "Patient Advocate Report(s)" dated January, February, April, May, June, July, August and September 2015 revealed the following information: (the March report could not be located)

In January 2015, the facility documented six "On The Spot Complaints" and 22 "Patient Grievances" which included five (5) different departments; Pharmacy, the Emergency Room (ER), Out Patient Clinic (OPC), Inpatient Care (IPC) the Dental Department and the Eye Clinic. The complaints and grievances centered on topics such as: Pain management, infection control, professionalism, rude employees, language barriers, improper diagnoses, discrimination, transportation and payment issues.

In February 2015, the facility documented three "On The Spot Complaints" and 10 "Patient Grievances" which included six different departments; Pharmacy, ER, OPC, IPC, Pediatrics (PEDS), and Obstetrics (OB). The complaints and grievances centered on topics such as: Disability access, evaluation/treatment, elderly assistance, communication, and customer service.

In April 2015, the facility documented two "On The Spot Complaints" and" five Patient Grievances" which included five different departments; Pharmacy, ER, OPC, PEDS, and Purchased/Referred Care (PRC). The complaints and grievances centered on topics such as: Evaluation/treatment, customer service, PCR dental care, confidentiality, and disability services.

In May, the facility documented 14 "On The Spot Complaints" and 29 "Patient Grievances" which included 12 different departments; OPC, Surgery, Pharmacy, PRC, Midwife (MW), Durable Medical Equipment (DME), IPC, Behavioral Health (BH), Eye Clinic, Mobile Unit, and Ear, Nose and Throat (ENT). The complaints and grievances centered on topics such as: Referrals/denials, evaluation/treatment, pain medications, medical equipment, communication, confidentiality, and customer service.

In June, the facility documented 11 "On The Spot Complaints" and 27 "Patient Grievances" which included seven different departments; OPC, PRC, IPC, BH, ER Acute Care (AC) and Dental. The complaints and grievances centered on topics such as: Referrals/denials, evaluation/treatment, pain medications, transfers, scheduling appointments communication, and customer service.

In July 2015, the facility documented 11 "On The Spot Complaints" and 12 "Patient Grievances" which included six different departments; Pharmacy, ER, OPC, IPC, OB and AC Nursing (ACN). The complaints and grievances centered on topics such as: Medications/supplies, disability access, evaluation/treatment, referrals/denials, scheduling/appointments, pain medication/refills, customer service and confidentiality.

In August 2015, the facility documented 10 "On The Spot Complaints" and 17 "Patient Grievances" which included 11 different departments; Pharmacy, ER, OPC, PRC, Midwife (MW) IPC, PEDS, Surgery, Dental, ENT, and ACN. The complaints and grievances centered on topics such as: Medications/supplies, disability access, evaluation/treatment, referrals/denials, scheduling/appointments, customer service, confidentiality and housekeeping.

In September 2015, the facility documented 14 "On The Spot Complaints" and 14 "Patient Grievances" which included 11 different departments; Pharmacy, ER, OPC, PRC, MW, IPC, PEDS, Surgery, Dental, ENT, Eye Clinic, Radiology and AC. The complaints and grievances centered on topics such as: Medications/refills, medical bills, appointments, transfers, evaluation/treatment, appointments and customer service.

Review of the facility's policies and procedures revealed a document titled, "Patient Grievance" reviewed 3/5/15 which provided the following information:

" ... The Patient Rights Advocate is responsible for the grievance process operation. The Patient Rights Advocate will report to the Hospital QAPI Committee monthly ... "

An interview with the Supervisory Engineer/Acting QAPI Coordinator and the Performance Improvement (PI) Administrator on 10/28/15 at 11:30 AM revealed that the facility had three different QAPI teams; one for Nursing Staff, one for Ancillary Staff and another for Medical Staff. The QAPI Coordinator stated that on a monthly basis, each of the three QAPI team members would hold a meeting to discuss each department's individual problems and potential concerns. Once the minutes from the team meeting had been documented, the information would be given to the "Quality Management Oversight Committee" (QMOC). The QMOC members were responsible for developing plans of action with measureable goals and time tables to ensure that the identified concerns from each QAPI team meeting would be prioritized, addressed and managed to ensure that the identified concerns would not continue in the future.

Review of the QMOC meeting minutes for the months of January, February, March, and April 2015 revealed that the QMOC committee did not discuss the patient complaints or grievances that were documented in the "Patient Advocate Reports(s)."

An interview with the QAPI Coordinator on 10/29/15 at 10:30 AM confirmed that it was the responsibility of the QMOC committee members to review the summary reports from the Patient Advocate Reports and develop plans of actions with measureable goals and positive outcomes; however, the QAPI Coordinator stated that the collected data from the Patient Advocate Report(s) had yet to be analyzed, tracked or trended by the QMOC. The QAPI Coordinator stated that the hospital did not have a plan for going forward to ensure that the patient's grievances and complaints would be addressed by the QMOC in the future.

Based on record review, interview and review of the policies and procedures, the facility failed to ensure that their Quality Management Oversight Committee (QMOC) had an ongoing program that indicated measureable improvements and outcomes for identified concerns. The QMOC did not analyze and track indicators relative to acute and chronic pain that was experienced by their patients, consequently the QMOC committee did not develop plans of actions with measureable goals and timetables to ensure that each patient's pain would be addressed and managed in the future.

Findings include:

Review of the "Patient Advocate Report(s)" dated January, February, (March could not be located) April, May, June, July, August, and September 2015, revealed that many patient's experienced acute and chronic pain which was documented in the monthly "Patient Advocate Report(s) " Review of the advocate reports revealed the following information:
In January 2015, there were 11 complaints/grievances that were related to pain management and/or receiving medications.

In February 2015, there were two complaints/grievances that were related to pain management and/or receiving medications.

In April 2015, there were two complaints related to pain management.

In May 2015, there were 14 complaints/grievances that were related to pain management and/or receiving medications.

In June 2015, there were 24 complaints/grievances that were related to pain management and/or receiving medications.

In July 2015, there were 14 complaints/grievances that were related to pain management and/or receiving medications.

In August 2015, there were 13 complaints/grievances that were related to pain management and/or receiving medications.

In September 2015, there were 14 complaints/grievances that were related to pain management and/or receiving medications.

Review of the Quality Management Oversight Committee (QMOC) meeting minutes revealed that the committee members did not discuss the pain management and medication issues that were documented in the "Patient Advocate Report(s)." The following information was obtained from the (QMOC) meeting minutes:

Review of the 1/29/15 minutes from the QMOC meeting, revealed that the committee members did not discuss the 11 documented complaints/grievances relative to the patients' pain management and medication administration.

Review of the 2/25/15 minutes from the QMOC meeting, revealed that the committee members did not discuss the two documented complaints/grievances relative to the patients' pain management and medication administration.

Review of the 3/25/15 minutes from the QMOC meeting, revealed that the committee members did discuss pain management. Under the, column titled, "Medical Staff QAPI (Quality Assessment and Performance Improvement) Pain Management", the following information was documented, "Pain Management: to update policy and to include the pain management appeal process, at this point this policy is outdated and did not include any pain policy this appeal process ... "

An interview with the Patient Representative on 10/28/15 at 1:15 PM revealed that she was responsible for collecting all of the information relative to the patients' complaints/grievances relative to pain management and medication administration and she was also responsible for writing the monthly "Patient Advocate Report(s)." She added that the March 2015 "Patient Advocate Report" could not be located; consequently the number of patient complaints/grievances relative to pain could not be determined. The Patient Representative added that she was not a member of the QMOC committee and she did not attend their monthly meetings. When interviewed about how the patients' pain management and medication administration complaints/grievances would be brought to the attention of the QMOC committee if she did not attend those meetings, the Patient Representative stated she was unsure.

Review of the 4/25/15 minutes from the QMOC meeting, revealed that the committee members did discuss pain management. Under the, column titled, "Medical Staff QAPI (Quality Assessment and Performance Improvement) Pain Management", the following information was documented, "Pain Management: to update policy and to include the pain management appeal process, at this point this policy is outdated and did not include any pain policy this appeal process ... " However, the committee members did not discuss the two (2) documented patient complaints/grievances relative to pain that occurred during the month of April 2015.

Review of the facility's policies and procedures revealed a document titled, "Patient Grievance" reviewed 3/5/15 which provided the following information:

" ... The Patient Rights Advocate is responsible for the grievance process operation. The Patient Rights Advocate will report to the Hospital QAPI Committee monthly ... "

An interview with the Supervisory Engineer/Acting QAPI Coordinator on 10/28/15 at 2:00 PM revealed that she was the acting QAPI Coordinator and she added that it was "very difficult" to get the necessary professionals to attend the QAPI monthly meetings. She stated that each member of the QMOC should be present at the meetings to ensure that committee could set priorities and address the identified concerns within each department in a timely fashion. The QAPI Coordinator stated that the facility did not have a meeting in May 2015 or July 2015 due to poor attendance. She added that the facility had three different QAPI teams; one for Nursing Staff, one for Ancillary Staff and another for Medical Staff. Per the QAPI Coordinator there was a "Quality Management Oversight Committee" (QMOC) that was responsible for gathering all of the information from the three separate QAPI team meetings and it was their responsibility to develop plans of action, set priorities and develop interventions with measureable goals and time tables to ensure that the identified concerns from each department would be addressed and not continue in the future.

An interview with the Performance Improvement (PI) Administrator and the Supervisory Engineer/Acting QAPI Coordinator on 10/28/15 at 2:15 PM confirmed that the information that was collected and documented in the "Patient Advocacy Report(s)" relative to the patients complaints/grievances relative to pain was not discussed during the QMOC meetings; consequently there were no plans of action to improve the pain management and medication administration outcome for their patients in the future.

Based on interview, record review and observation, the facility failed to ensure that their Quality Management Oversight Committee (QMOC) reviewed the documented issues and concerns from each Quality Assessment and Improvement Program (QAPI) to ensure that there was an ongoing Performance Improvement (PI) Plan for each department of the hospital. The QMOC did not conduct performance improvement projects relative to: 1) Patient grievances and complaints, 2) pain management and medication administration, 3) the operation of the kitchen's essential equipment, 4) the attendance of the OMOC committee members during the monthly meeting or 5) to address the findings from the 7/16/15 EMTALA investigation and failed to ensure that the Plan of Correction provided to correct the deficient practices was monitored and implemented.

Findings include:

1. Review of the "Patient Advocate Report(s)" dated January, February, April, May, June, July, August and September 2015 revealed that the facility had many patient complaints and grievances within multiple departments throughout the hospital.

Review of the QMOC monthly meetings dated 1/29/15, 2/25/15, 3/25/15 and 4/25/15 (the QMOC did not meet in May, June or July) revealed that the QMOC members did not discuss the patient multiple complaints and grievances and they did not develop a performance improvement program to improve patient satisfaction.

2. Review of the "Patient Advocate Report(s)" dated January, February, (March could not be located) April, May, June, July, August, and September 2015, revealed that many patients experienced acute and chronic pain which was documented in the monthly "Patient Advocate Report(s)."

Review of the QMOC meeting minutes revealed that the committee members did not discuss the pain management and medication issues that were documented in the "Patient Advocate Report(s)" and the QMOC members did not develop a performance improvement program to assist with pain management and medication administration for their patients.

3. Observation of the kitchen on 10/26/15 at 11:00 AM revealed there were several pieces of equipment that did not work effectively. The dish machine was inoperable, the large metal mixer was also non-functional, the lower part of the steamer was broken and the rubber drain screen that covered the opening of the garbage disposable had disintegrated and was not functioning effectively.

An interview with the Supervisory Dietary Worker (SDW) on 10/26/15 at 11:15 AM confirmed that the equipment listed above was broken and inoperable. The SDW stated that the kitchen staff had not utilized the dish machine to clean and sanitize the dishware for approximately three years. He added that because the dish machine was inoperable, the patients and staff had to eat their meals on disposable dishes. When interviewed about the mixer and steamer, the SDW stated that they had been broken for approximately three months. In addition, he stated that the rubber screen/drain cover that was over the opening of the garbage disposable had disintegrated some time ago.

Review of the QMOC meeting minutes revealed that the committee members did not discuss the operation of the kitchen and they did not develop a performance improvement program to ensure that their equipment would be repaired timely.

4. An interview with the Supervisory Engineer/Acting QAPI Coordinator on 10/28/15 at 11:30 AM revealed that she was the acting QAPI Coordinator and she added that it was "very difficult "to get the necessary professionals to attend the QAPI monthly meetings. The QAPI Coordinator stated that the facility did not have a meeting in May 2015 or July 2015 due to poor attendance. Per the QAPI Coordinator there was a "Quality Management Oversight Committee" (QMOC) that was responsible for gathering all of the information from the departmental QAPI team meetings and it was the QMOC's responsibility to develop plans of action with measurable goals and time tables to ensure that the identified concerns from each department would be addressed and not continue in the future.

Review of the sign in sheets revealed that each month a different set of committee members were expected to attend the QMOC meetings and their names were printed on the sign in sheets. The following information was obtained from the individual sign in sheets:

· In January 2015, the meeting was held on the 29th and the Assistant Director of Nursing (ADON) and the Laboratory Supervisor did not attend the meeting.

· In February 2015, the meeting was held on the 25th and the following committee members did not attend the meeting: The Chief Executive Officer (CEO), Administrative Officer, ADON, Pharmacists, Laboratory Supervisor, Information Technology (IT), and Medical Staff QAPI Chair.

· In March 2015, the meeting was held on the 25th and the following committee members did not attend the meeting: Facilities Manager, ADON, Pharmacists, Laboratory Supervisor, Radiology Supervisor, IT, Medical Staff/Clinical Director (CD), or two Medical Staff QAPI Chairs.

· In April 2015, the meeting was held on the 22nd and the following committee members did not attend the meeting: Deputy Chief Executive Officer (DECO), Administrative Officer, ADON, Medical Staff /CD, and the Medical Staff QAPI chair.

· There was not a meeting in May 2015

· In July 2015 the meeting was to take place on the 22nd. However, because most of the committee members did not attend, the meeting was canceled.

· There were not any QMOC meetings held in August, September or October 2015.

Review of the sign in sheet for the Medical Staff QAPI meeting that was held on 10/1/15 revealed that many of the pertinent committee members did not attend the meeting. The following members were absent during that meeting: Emergency Department Director, Midwife Supervisor, Deputy Clinical Director, Out-Patient Department (OPD) Supervisor, Optometry, Hospitalist, Operating Room(OR)/Surgeon, Dental, Medical Staff Coordinator, and the QAPI Representative.

An interview with the QAPI Coordinator on 10/29/15 at 2:00 PM revealed that she was aware of the identified concerns that were discussed at the QAPI meetings among the different departments within the hospital. When interviewed about how the concerns were to be addressed and managed through the QMOC meetings if the pertinent staff did not attend the Medical Staff QAPI meetings or the QMOC meetings, the QAPI Coordinator stated she was unsure, but she reiterated that it was "very difficult" to get the committee members to attend the meetings, consequently many of the issues continued to be a concern.

Review of the QMOC meeting minutes revealed that the committee members did not discuss the poor attendance at the meetings and they did not develop a performance improvement program to ensure that the appropriate members would be available to attend the meeting in the future.

A follow up investigation to the 7/16/15 EMTALA investigation showed the Hospital failed to address the findings and ensure that the Plan of Correction provided to correct the deficient practices was monitored and implemented.

Based on record review and interview the facility failed to ensure that the Governing Body/Executive Committee completed their responsibilities to oversee the Quality Management Oversight Committee (QMOC). The QMOC committee members were absent from the meetings; consequently the committee members could not develop a plan of action with measurable goals with timetables to ensure that the identified concerns could be prioritized, addressed and managed effectively.

Findings include:

An interview with the Supervisory Engineer/Acting Quality Assurance and Performance Improvement (QAPI) Coordinator, on 10/28/15 at 11:30 AM, revealed that she was the acting QAPI Coordinator and she added that it was "very difficult" to get the necessary professionals to attend the Quality Management Oversight Committee (QMOC) monthly meetings. She stated that each member of the QMOC should be present at the meetings to ensure that the concerns identified in each department could be addressed in a timely fashion. The QAPI Coordinator stated that the facility did not have a meeting in May 2015 or July 2015 due to poor attendance.

Review of the QMOC sign in sheets revealed the following professionals were members of the "Quality Management Oversight Committee:"

The Chief Executive Officer (CEO)
Deputy Chief Executive Officer (DCEO)
Administrative Officer
Director of Nursing (DON)
Assistant Director of Nursing (ADON)
Facilities Manager
Pharmacy Supervisor
Two Pharmacists
Laboratory Supervisor/Designee
Radiology Supervisor
Information Management/IT
Information Technology (IT)
Risk Management
Medical Staff/Clinical Director (CD)
Medical Staff/Deputy Clinical Director (DCD)
Two Medical Staff QAPI Chairs
Quality Management Representative/Performance Improvement (PI) and
Two Out-Patient Clinic Representatives

Review of the sign in sheets revealed that each month a different set of committee members were expected to attend the QMOC meetings and their names were printed on the sign in sheets. The following information was obtained from the individual sign in sheets:

· In January 2015, the meeting was held on the 29th and the ADON and the Laboratory Supervisor did not attend the meeting.

· In February 2015, the meeting was held on the 25th and the following committee members did not attend the meeting: The CEO, Administrative Officer, ADON, Pharmacists, Laboratory Supervisor, IT, and Medical Staff QAPI Chair.

· In March 2015, the meeting was held on the 25th and the following committee members did not attend the meeting: Facilities Manager, ADON, Pharmacists, Laboratory Supervisor, Radiology Supervisor, IT, Medical Staff/CD, or two Medical Staff QAPI Chairs.

· In April 2015, the meeting was held on the 22nd and the following committee members did not attend the meeting: DCEO, Administrative Officer, ADON, Medical Staff /CD, and the Medical Staff QAPI chair.

· There was not a meeting in May 2015

· In July 2015 the meeting was to take place on the 22nd. However, because most of the committee members did not attend, the meeting was canceled.

· There were not any QMOC meetings held in August, September or October 2015.

Review of the sign in sheet for the Medical Staff QAPI meeting that was held on 10/1/15, revealed that many of the pertinent committee members did not attend the meeting. The following members were absent during that meeting: Emergency Department Director, Midwife Supervisor, Deputy Clinical Director, Out-Patient Department (OPD) Supervisor, Optometry, Hospitalist, OR/Surgeon, Dental, Medical Staff Coordinator, and the QAPI Representative.

Review of the QMOC meeting minutes dated, 1/29/15, 2/25/15, 3/25/15 and 4/25/15 revealed that the committee members did not discuss the poor attendance of the members; consequently they did not develop a plan of action with measurable goals to ensure that the problem would not continue in the future.

An interview with the QAPI Coordinator, on 10/29/15 at 2:00 PM, revealed that she was aware of the identified concerns that were discussed at the QAPI meetings among the different departments within the hospital. When interviewed about how the concerns were to be addressed and managed through the QMOC meetings if the pertinent staff did not attend the Medical Staff QAPI meetings or the QMOC meetings, the QAPI Coordinator stated she was unsure, but she reiterated that it was "very difficult" to get the committee members to attend the meetings, consequently many of the issues continued to be a concern.

Based on record review and staff interviews the medical staff failed to show its accountability related to its approval of polices and procedures as required for their leadership participation in the organization. The medical staff failed to ensure that a new program for "Respiratory Services" and its policies and procedures had been reviewed and approved. Additionally, the medical staff failed to ensure that the pain directive was used to address pain management in the Emergency Department and Outpatient Department.

Findings include:

1. The Hospital's Plan of Correction for the 7/16/15 EMTALA investigation stated:

"All patients who present to the ER with a complaint of pain, request for pain medication or chronic pain receive an appropriate Medical Screening exam to rule out an acute medical condition...Appropriate medical interventions needs to be accomplished, including the prescribing of medication if appropriate. Pharmacy must honor medication requests for treatment of acute pain condition."

a. Medical record review for patient #27 evidenced that the patient presented to the Outpatient Department on 10/22/15 at 1:16 PM with a complaint of right eye pain after being struck in the eye with a baseball bat. The patient indicated that blood came out of the eye and her pain level was 10 out 10. She reported a 15 minute loss of consciousness. The patient was diagnosed with an open fracture of the right orbit and was transferred to the ER without being medicated.

The patient was admitted to the ER at 5:03 PM with a pain level of 10, medicated with Morphine Sulfate 4 mg IV. At the time of discharge (6:30 PM) her pain level was still 8 out of 10. She was given Tramadol for pain.

The patient returned to the ER on 10/15/15 at 1:23 PM with a pain level of 10. She was medicated with Morphine 4 mg mixed with Zofran 4 mg IM. She was given Tramadol 50 mg three times a day. At the time of discharge (2:30 PM) the patient's pain level was 9 out of 10.

Pain levels of 8 and 9 fail to show that the patient's acute pain was managed effectively.

b. Review of an e-mail from the Acting Clinical Director to the providers with copies to the Administrative staff, dated 8/26/15, with a subject of chronic pain patients revealed the following:

"Due to the current shortage of IPC providers I am authorizing ER providers and Same Day Clinic providers to prescribe chronic pain medications to patients with chronic pain contracts according to the terms of their contract. For patients who do not have a chronic pain contract, ER providers and Same Day Clinic providers are authorized to write for 1-3 days of controlled medication only."



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2. An interview with the respiratory therapist on 10/27/15 at 12:50 PM revealed she was contracted for providing respiratory services back in February of 2015. She stated that the respiratory service provided was a basic level of respiratory care.

a. Review of the "Respiratory Therapy Policies and Procedures" revealed they had not been reviewed or approved by the medical staff which were being used for the past nine months.

b. An interview with the medical director on 10/27/15 at 3:35 PM confirmed the respiratory care policies and procedures had not been reviewed or approved by the medical staff. (Refer to A1160)

Based on record review and staff interview, it was determined that the Hospital failed to ensure that eight of 46 sample patients' medical records (#31, #32, #37, #38, #39, #40, #41, and #44) were complete and accurate. The findings included:

1. Review of the Emergency Room (ER) record for patient #31's 10/20/15 visit to the Emergency Department (ED) at 11:21 PM revealed that the medical provider (A) charted that he arrived at the patient's bedside at 11:35 PM on 10/21/15.

On 10/29/15, in interview with the Director of Nursing (DON), she verified that the provider just picked the wrong "drop-down" date in the electronic health record (EHR).

Additionally, the patient was given Haldol 10 mg and was restrained in four point restraints. No orders for this dosage of medication or for the use of the restraints were found in the ED chart which was provided to the surveyor as a complete record for the 10/20/15 visit.

2. Review of the Emergency Room (ER) record for patient #32's visit to the Emergency Department (ED) on 9/29/15 at 10:35 AM revealed that the patient, a 43 year old male, presented with a chief complaint of pain all over. The nurse (D) notified the provider (A) at 12:46 PM that the patient was in the exam room. The physician arrived at 12:50 PM, examined the patient, and discharged him to home at 12:58 PM. The physician's assessment which specified the visit diagnoses stated "1) Chronic pain syndrome and 2) Dispensing medication. The diagnoses were followed by "51 y/o female with hx of DM non adherence to treatment for 2 months, , comes due has dizzy asociayted to blurred vision and thirsty...stbale vital sign, no respiratory distres or chest pain..no neurological deficit, pt is alert, oriented, cooperative..labs will be performed to asses her metabolic state inclunding blood sugars levels..."

3. Review of the Emergency Room (ER) record for patient #37's visit to the Emergency Department (ED) on 10/24/15 at 11:40 AM revealed that the patient was brought from the jail for self injurious behaviors (suicidal behavior). The patient was assessed, treated, and discharged to jail at 1:17 PM. The documentation lacked a pain level assessment on admission and discharged and did not have discharge vital signs noted.

4. Review of the Emergency Room (ER) record for patient #38's visit to the Emergency Department (ED) on 10/24/15 at 3:58 AM revealed that the patient arrived via ambulance after a suicide attempt. The patient was noted to have a history of previous suicide attempts and a diagnosis of major depression (new diagnosis of chronic depression added 3/15). At the time of transfer to another hospital, no pain assessment was documented.

5. Review of the Emergency Room (ER) record for patient #39's visit to the Emergency Department (ED) on 10/21/15 at 12:18 PM revealed that the patient arrived via ambulance with CPR in progress with respiratory failure and cardiac arrest. Review of the provider (E)'s notes evidenced the following statements which were inconsistent with the patient's condition:

"Patient complains of malaise", followed by "unresponsive"

"Alert, Oriented, Pupils normal" with Glasgow Coma Scale of 15, followed by "unresponsive" and Glasgow of 3 (indicating no response).

Plan "Pat will be sent to Rapid City Regional for evlaution" followed by "Follow-up prn increased symptoms".

6. Review of the Emergency Room (ER) record for patient #40's visit to the Emergency Department (ED) on 10/20/15 at 11:02 AM revealed that the patient indicated that she had been waiting in clinic but the pain was so bad she left. The patient complained of right lower quadrant pain and was 8 week pregnant. The provider (E)'s diagnosed the patient with low back pain followed by a complete abortion in the bathroom. When the patient was discharged at 2:50 PM, no pain assessment was documented.

On 10/29/15, in an interview with the DON, she verified that no pain level had been charted at the time of discharge.

7. Review of the Emergency Room (ER) record for patient #41's visit to the Emergency Department (ED) on 10/18/15 at 6:39 PM revealed that the patient's presenting complaint was pain under the ribs on both sides and kidney hurting. No pain level was charted at the time of the triage (7:29 PM).

8. Review of the Emergency Room (ER) record for patient #44's visit to the Emergency Department (ED) on 10/25/15 at 12:36 AM revealed that the patient presented with a chief complaint of an overdose. The provider (F) diagnosed the patient as a suicide attempt with an analgesic drug (for pain relief). The physician ordered a transport by Basic Life Support (ambulance). Review of the patient's Out-of-Hospital Transfer Record revealed that Basic Life Support was crossed off and "Security" was written in on the form. No initials were noted on the cross off nor was there an explanation of the change in plans for the transport.

On 10/29/15, in an interview with the DON, she revealed that this was a new provider who didn't complete the form correctly.


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9. Review of grievances on 10/27/15 identified issues with patient records. One of the grievances filed in June of 15 noted a patient complaint included a concern that the information in her medical record contained information about a male patient. The grievance form included, "OPC provider evaluated and treated the patient. He told her, she has multiple illnesses, such as liver disease, Hep C (hepatitis C), etc. Patient doesn't have any of these illnesses; it was discovered that a 63 year old male' documents were put in her chart..."

This was an example of a medical record containing information on two different patients. (See above #2. example for similar medical record documentation error.)

10. During interviews with staff, who did not want to be identified, reported that this was an ongoing problem. Staff reported that it was common knowledge and that staff including provider would copy and paste patient information from old charts in current patient records which resulted in multiple errors in the patients medical record as well as patients information getting into the wrong patients chart or medical record.

Staff reported that a prior governing board member had dealt with the problem in the past but without his direction staff including providers were not addressing the problem and continued the erroneous practice.

Based on medical record review, policy review and staff interview, the hospital failed to ensure staff timed and dated their authenticated signatures on the inpatient consent form and failed to complete out of hospital transfer forms for four of 46 sampled patients (#14, #42, #43 and #45).
Findings include:

1. Medical record review for Patient#14 revealed the patient was admitted to the hospital on 10/25/15 with a diagnosis of colonic ileus. Review of the "Inpatient Consent" form, revealed it lacked the time or date the Registered Nurse and Patient#14 signed the consent form.

On 11/28/15 at 3:00 PM, an interview with Staff #96 Registered Nurse (RN) Team Leader, verified Patient #14's "Inpatient Consent" form lacked the time and date the consent form was signed.

Review of the Hospital policy titled "Medical Record Documentation", revised 7/10/14, revealed the "Signatures of authentication" which stated all entries in the Health Record shall be timed, dated, initialed where appropriate and authenticated with full legible signatures.










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2. Review of the Emergency Room (ER) record for patient #42's visit to the Emergency Department (ED) on 10/19/15 at 6:14 PM revealed that the patient arrived via ambulance and was unresponsive. He was diagnosed with an altered mental status and a subdural hematoma. The patient was transferred via life flight. Review of the Out-of-Hospital Transfer Record revealed that the section for what was sent with the patient was left blank. This section includes copy of medical record, copy of health summary, copies of all lab results, copy of EKG, and copy of X-Rays and/or Reports.

3. Review of the Emergency Room (ER) record for patient #43's visit to the Emergency Department (ED) on 10/25/15 at 12:47 AM revealed that the patient was diagnosed with recurrent major depression and suicidal thoughts. The patient was transferred via ambulance. Review of the Out-of-Hospital Transfer Record revealed that the section for what was sent with the patient was left blank. This section includes copy of medical record, copy of health summary, copies of all lab results, copy of EKG, and copy of X-Rays and/or Reports.

4. Review of patient #45's Out-of-Hospital Transfer Record for 10/11/15 at 12:23 PM revealed that the sections for what was sent with the patient and preparation for transfer of patient were left blank. These sections include copy of medical record, copy of health summary, copies of all lab results, copy of EKG, and copy of X-Rays and/or Reports and any medical devices in use and approval for the transfer was marked to show that the transfer was explained to and accepted by the patient. The condition at time of transfer, personnel escorting patient, and the criteria for transfer sections of the form were also not filled in. The referring physician certifications and referring physician consultation certification sections were blank.

Based on observation, record review, and staff interview, it was determined that the Hospital failed to store Mannitol according to acceptable professional standards.

Findings included:

On 10/26/15 at 11:25 AM, during an observation in the Emergency Department (ED) trauma room in the presence of the Acting CEO and nurse (D), a black box with a seal on it was observed in the warmer. The nurse reported that the box was where the current form of Mannitol was being stored and that the temperature was monitored and written on the log.

On 10/26/15 at 1:42 PM, in an interview with the Chief Pharmacist, she was asked about the proper storage for the Mannitol. She indicated that she was not aware of a policy for the use of Mannitol.

On 10/27/15 at 9:20 AM, in response to the question, she provided her investigation into the stability of Mannitol. Her summary revealed the following:

The package insert for mannitol vials did not provide data on the stability of vials stored in a warmer.

The manufacturer did not provide data.

A call to a larger hospital revealed that their practice was to store at room temperature.

A reference was found in Trissel's Handbook on injectable drugs 17 th Edition, copywrite 2013. "As an alternative to resolubilizing techniques, the use of warming chambers to maintain the solutions in a crystal-free condition has been recommended." However, the reference did not site the number of days the product would be stable and the reference was dated 1975.

Vials were pulled from the warmer and placed with expired/unusable medications to be returned.

One liter bags were obtained and stocked in the ED trauma room Omnicell. This change was communicated to staff.

Based on observation and staff interviews, the hospital failed to ensure all drugs and biologicals were kept in a secure and locked area.
Findings include:

During a tour of the operative suite conducted on 10/26/15 at approximately 11:15 AM, an anesthesia cart in the "C-Section Suite" was noted to contain a variety of unopened medications, needles and syringes on top of the cart. Entrance to the suite revealed staff, patients and visitors could enter the area through an unlocked door from the labor and delivery unit, and was readily accessible to patients and visitors. The medications included Pitocin, Lidocaine, Zofran, Phenylephrine, Dexamethasone, Succinylcholine, Cephazolin and Ephedrine which were used for cesarean sections.

During an interview with the Certified Registered Nurse Anesthetist (CRNA) on 10/26/15 at 11:15 AM, he stated he put the unopened medications and syringes on top of the anesthesia cart as he "likes to be ready at all times."

Based on observation, policy review and staff interview, the hospital failed to ensure kitchen equipment was safely maintained and operational, chemicals were safely stored, thermometer probes were sanitized, outdated biologicals were not available for patient use and oxygen cylinders were secured and stored safely for all patients.

Findings include:

1. Observation of the kitchen on 10/26/15 at 11:00 AM revealed there were several pieces of equipment that did not work effectively. The dish machine was inoperable, the large metal mixer was also non-functional, the lower part of the steamer was broken and the rubber drain screen that covered the opening of the garbage disposable had disintegrated and was not functioning effectively.

An interview with the Supervisory Dietary Worker (SDW) on 10/26/15 at 11:15 AM, confirmed that the equipment listed above was broken and inoperable. The SDW stated that the kitchen staff had not utilized the dish machine to clean and sanitize the dishware for approximately three years. He added that because the dish machine was inoperable, the patients and staff had to eat their meals on disposable dishes. When interviewed about the mixer and steamer, the SDW stated that they had been broken for approximately three months. In addition, he stated that the rubber screen/drain cover that was over the opening of the garbage disposable had disintegrated some time ago.

Review of the dish machine temperature logs revealed that the last time the kitchen staff utilized the dish machine to wash and sanitize the cookware was February 2013.

An interview with the Facility Supervisory Engineer and the SDW on 10/26/15 at 3:15 PM revealed that the maintenance department was aware of the broken dish machine and had continually purchased parts for the machine but they were not aware of the broken mixer, steamer and drain screen/cover. When interviewed about why the dish machine remained inoperable if the facility continued to purchase replacement parts, the SDW and the Facility Supervisory Engineer stated they were uncertain.

Observation of the kitchen during the initial tour on 10/26/15 at 10:30 AM revealed a "ready to eat" cake had been prepared for the lunch meal. The cake was placed on a metal sheet pan and was ready for consumption. Placed directly next to the ready to eat cake, was a plastic bottle that contained a blue cleanser. There was a potential for cross contamination when food and chemicals are stored within close proximately of each other. An interview with the SDW at that time, confirmed that the blue cleanser should not have been stored directly next to the ready to eat cake.

Observation of the kitchen on 10/26/15 at 11:45 AM, revealed that the lunch meal was prepared and ready for service. When asked to take the food temperatures to ensure safety, the Cook gathered a thermometer from the SDW's shirt pocket, removed it from the sleeve, and placed the temperature probe into the bean and bacon soup without first sanitizing it. The Cook and the SDW confirmed at that time, that the thermometer probe should have been sanitized before placing it into ready to eat food to ensure food safety.


2. Observation during the initial tour of the facility on 10/26/15 at 11:30 AM, revealed an oxygen cylinder tank standing unsecured on the floor stored next to crash cart at the nurse's station. Further observation on 10/27/15 at 3:30 PM, revealed the oxygen cylinder remained unsecured standing on the floor at the nurse's station.

On 10/27/15 at 3:30 PM an interview with the Registered Nurse (RN) (# ) Team Leader, confirmed the oxygen cylinder is required to be secured in a cart so the cylinder cannot fall over.

Review of the Hospital policy titled "Compressed Gas and Oxygen Use #3007", revised 10/15/15, revealed "PROCEDURE: GENERAL STANDARDS", which revealed cylinders must be secured at all times so they cannot fall.


3. Observation during the initial tour of the Acute Care Nursing (ACN) unit on 11/26/15 at 11:30 AM, revealed the following outdated infant formula:

A. Two-Gerber Good Start Gentle, 12.9oz, cans of powder infant formula with an expiration date of 5/6/15.

B. One Enfamil Prosobee, 12.9oz can of soy powder infant formula with an expiration date of 7/1/15.

C. One Enfamil Gentlease, 12.9oz can of powder infant formula with an expiration date of 10/1/15.

On 11/26/15 at 11:40 AM, an interview with Staff #25 Registered Nurse Supervisor verified the four cans of infant formula were outdated and needed to be discarded as required by the hospital policy.

Review of the hospital policy titled "Supply Management" revealed "Aberdeen Area Policies & Procedures Manual, Section 5F Inventory Management (2) Cupboard Stock Audits: " which revealed once supplies are issued to departments, the department becomes responsible for the management of those supplies including ensuring that supplies do not become expired or obsolete. The department supervisor shall make monthly inspection of all cupboard stock to ensure no expired or obsolete or excess supplies are present.

Based on observations, record review and staff interviews, it was determined that the Hospital failed to ensure that there was an active infection control program that monitored, investigated, controlled, and/or prevented or decreased the opportunities for the spread of infections. This also related to the failure to ensure adequate processing of contaminated reusable medical instruments and the proper use of mechanical sterilizers.


Findings included:


1. During the initial tour of the outpatient departments on 10/26/15 at 10:30 AM infection control issues were identified with the processing of dirty instruments and the use and maintenance of sterilizers. The issues included:

a. The room being used by Podiatry was noted to have dirty instruments setting in a basin under the sink. The instruments were partially covered with a small blue towel. There was no solution on the instruments and the provider was not aware how his nurse normally handled dirty instruments. The provider reported he considered this room to be a dirty/contaminated room. He also reported due to high numbers of the patients in the community with MRSA (Methicillin Resistant Staph Aureus) infections he treats everyone as having an infection. He voiced a concern about finding a clean room when he had to do clean type procedures.

Nurse Supervisors (AA) and (BB) confirmed that space was limited and there was not a soiled utility room in the outpatient department where dirty or used instruments could be processed prior to going the central supply. Nurse (AA) and (BB) were not aware of the procedure the podiatry staff (DD) was using or supposed to use in handling dirty instruments. The staff (DD) who handled the instruments was not working.

Note: The follow up on 10/27/15 with staff (DD) revealed there was supposed to be a red container with a lid in which dirty instruments are placed. She report she uses a spray foam called "Prepzyme XF" on dirty / soiled instruments. The directions indicate chemical used to prevent bio-burden from adhering to the surface of soiled instruments. She sprays the instruments before putting them into the red bin and later in the day takes them to central supply for processing. She also indicated that the infection control staff had checked with her early in the day about her procedure. The practice of allowing blood and other bioburden to dry on instruments has the potential of making it more difficult to remove and compromise the effectiveness of the subsequent disinfection and sterilization.


b. The tour of the ENT clinic found dirty nasal instruments and hemostats setting in a basin in the sink uncovered. Staff was asked about procedure for handling dirty instruments. She reported she usually soaked instruments for 15 minutes then put them in the small counter "UtraClave" sterilizer. She then reported was not sure about the machine and asked nurse (EE) about the process.

Nurse (EE) reported she was new and had only been in the position for about a month but she had run a cleaning process for the machine. The instruments were to be soaked right away and then they would be put in the "UltraClave" sterilizer. There was no log available for testing or cleaning of the "UltraClave" sterilizer. She also confirmed she had not been trained as to the departments processes for handling of dirty/soiled equipment.

NOTE: A later investigation and interviews found that the "UtraClave" equipment in ENT had not been used for a long time and was not supposed to be used. The staff from central supply was actually picking up dirty instruments and taking them back to the central supply for processing sterile equipment.


c. The tour of the dental clinic found the clinic had three "AutoClave" sterilizers. One of the machines was marked as not in use. The check of the logs for the spore testing on the machines that were currently in use were found to be incomplete. The log showed no documentation from 1/5/15 to 8/10/15 of testing or indication of the machine not working. A note on 9/28/15 stated, "not working". The dental staff providing the log was unsure why the log was incomplete. A follow up interview with Biomed and maintenance staff confirmed the sterilizers in the dental clinic were an ongoing problem and the unit was not working for a long period of time. However that information was not reflected in the tracking logs.


d. During the tour of the clinic in Kyle on 10/28/15 staff was observed using an small counter top Autoclave sterilizer in the women's clinic. Staff reported she had been trained on using the machine from a previous employee. She had not had formal training or competency training on the use of the sterilizer. Interview with the staff (GG) responsible for infection control in the clinic reported that she had received a new form for competency which had not been started. The form was entitled "Instrument Cleaning, Wrapping/Packing and Sterilization".

e. During the tour of the clinic in Wamblee on 10/28/15 nurse (HH) reported that their Autoclave sterilizer was not working and they were trying to get a new sterilizer. They were current having the staff in the dental clinic run and instruments when it was need. The staff was not aware of any type of competency training for the use of the sterilizer.

f. During observations in the emergency room on 10/26/15 and 10/29/15 dirty instruments were observed to be sitting in a dry basin in the soiled utility room uncovered. Interview with the IC (infection control) nurse on 10/29/15 during the observation confirmed that dirty instruments should be in a solution to decrease bio-burden and then put into a covered red bin to be taken to central supply for processing.

The isolation room in the ER department was also checked. There were no gowns or masks readily available to handle a patient coming into this room needing isolation. The IC nurse reported that the room should be set up with all PPE (personal protective equipment).

The facility failed to ensure infection control policies specific to each department were in place. This included the training and monitoring the procedure for handling of dirty or soiled reusable instruments and the use of sterilizers to ensure those infection control measures were being followed to prevent or decrease the opportunities for the spread of infections.

2. Interview with the IC (infection control ) nurse on 10/28/15 and review of the infection control logs identified the following:

a. The infection control tracking log had not been completed for September 2015. The IC nurse reported she had been busy with giving flu vaccinations and was unable to get the tracking done. She also confirmed that the overall rates for MDRO (multiple drug resistant organisms) was high. The MRSA rate for the second quarter of the year was 57%. The tracking for July 2015 showed the MRSA rate was 7.8% which was increase from June at 3.2%. However there was no tracking completed for August and September (2015).

b. After the IC nurse was notified the survey team had questions about handling of dirty reusable instrument she found staff had not been following the hospitals policies and procedures. Additionally, she had no documentation of staff training on proper use of sterilizers.

c. There were monthly infection control meetings however the IC nurse was not part of the overall hospital wide QAPI (Quality Assessment and Improvement) committee. She was not aware how departments were monitoring infection control practices. She expressed concerns with getting staff to be involved with a comprehensive hospital-wide infection control program.

Based on medical record review, staff interviews and policy review, the hospital failed to ensure that an operative report describing techniques, findings, and tissues removed or altered was written or dictated immediately following surgery and signed by the surgeon for two of seven sampled surgery patient records (#18 and #35).

Findings include:

1. A review of the medical record of Patient#18, who underwent surgery on 10/26/15, revealed no evidence of an operative report. In an interview conducted on 10/26/15 at 3:20 PM, the Health Information Management (HIM) Administrator (Employee #9) stated "The doctor dictates the note and we get it later. He comes back once a month to sign it. If it's a STAT (Latin term meaning immediately) it gets done in one hour." When asked to determine if the note was dictated that day, she stated "there's supposed to be a note in here that says dictated. There is no dictated note" that indicated the operative report had been completed. She was unable to locate a progress note in the paper record and stated it could be in the pharmacy. Employee #9 called the pharmacy and was told the paper record was not there.

On 10/26/15 at 3:40 PM, Employee #9 was observed entering the operative suite with a paper medical record in her hand. She stated "I'm looking for the doctor to have him sign this they said he was up here." She was holding a "Doctor's Orders" sheet for Patient #18. She acknowledged there was no operative note dictated or in the progress notes.

2. A review of the medical record of Patient #35 conducted on 10/26/15 and 10/27/15 who underwent surgery on 10/26/15, failed to reveal a dictated operative report in the paper or electronic record. A handwritten progress note dated 10/26/15 at "15:10" briefly outlined the pre and post op diagnosis, procedure, type of anesthesia and disposition. It was signed and dated prior to the surgery which was documented with an anesthesia start time of "15:58" and a stop time of "16:47."

Based on observations, staff interviews and review of patient records and hospital policies, it was determined the hospital failed to ensure that a post anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia for two of 46 sampled patients (#35 and #36).

Findings include:

1. A review of the medical record of Patient #35 conducted on 10/28/15 revealed a post anesthesia evaluation that was signed, dated and timed, but not filled out. There was no assessment of respiratory function, cardiovascular or mental status, temperature, nausea or vomiting, pain level or post op hydration. In an interview conducted on 10/28/15 at 12 noon, the designated surgical lead (Employee #41) stated "the post anesthesia evaluation is supposed to be filled out and signed" at the time of the evaluation.

2. On 10/29/15 at 10:20 AM, while speaking with the Employee #41, Patient #36 was observed in the Post Anesthesia Care Unit (PACU) along with the spouse, two nursing students and a registered nurse. There was no anesthesia provider in the room. The patient chart was reviewed at 10:25 AM, it was noted the post anesthesia evaluation had been completed by the registered nurse, and signed by the CRNA (Employee #617) at 10:30AM. When interviewed, the Registered Nurse (RN) (Employee #40) admitted he had entered the post evaluation information early, and stated Employee #617 had pre-signed the evaluation. During an interview with Employee #617 at 10:37 AM, he stated "Yes, I did it. I apologize. I won't do it again. It's my way to keep from forgetting." At 10:38 AM, the designated surgical lead (Employee #41) confirmed that pre-signing the medical record was an issue.

A hospital policy titled "Post- operative Anesthesia Care" #7003, dated 9/23/14 stated "The Post-op evaluation by the CRNA (Certified Registered Nurse Anesthetist) will be documented on the PACU Admission Assessment & Discharge Record in the sections titled Anesthesia Post-Op Discharge Evaluation and be signed, dated and timed by the CRNA at the time of the evaluation."

Based on interviews and review of policies and procedures, the hospital failed to have written respiratory care policies and procedures approved by medical staff for the scope of the respiratory services being provided in the facility.

Findings included:

1. On 10/27/15 at 12:50 PM, an interview with the sole hospital respiratory therapist was conducted. She reported she had a contract for providing respiratory services, a new service, which started 2/17/15. She stated that the respiratory service provided was a basic level of respiratory care. She did pulmonary function testing, breathing treatments and assisted providers in setting up mechanical ventilation setting and oxygenation support when need in the emergency room. The interview also revealed the following:

a) There was a book entitled "Respiratory Therapy Policies and Procedures" which the Respiratory Therapist reported she had put together for the procedures she was doing in the facility. The policies and procedures were not dated or signed.

b) There no evidence the medical staff had reviewed or approved the respiratory care policies and procedures for the facility.

The Respiratory Therapist confirmed that the policies and procedures had been reviewed by the medical director but they had not been approved by the medical staff.

2. On 10/27/15 at 3:35 PM in an interview with the ACO (Acting Medical Director) he confirmed that he had seen the respiratory care policies and procedures book that the Respiratory Therapist had put together. However, the policies and procedures had not been reviewed or approved by the medical staff. He reported that the respiratory care contract was about up and the hospital was unsure if the service would be continued.